A Double Blind, Placebo-Controlled, Pilot Study to Estimate the Efficacy and Tolerability of Twice Daily Promiseb Topical Cream in Pediatric Subjects With Cradle Cap (Seborrheic Dermatitis)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Number of Participants With Excellent Overall Safety Score at End of Treatment.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Promiseb Topical Cream in cradle cap.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of cradle cap
- •Must be at least 30 days old
- •Must be in good health as determined by investigator
- •Naive to prior cradle cap therapy (may have used mineral, olive oils)
排除标准
- •Known food, topical product or medicinal allergies.
- •Prior use of corticosteroids, antifungals or keratolytics for Cradle Cap
- •Weighing less than 7 lbs
研究组 & 干预措施
Promiseb Topical Cream
干预措施: Promiseb Topical Cream (Device)
Bland emollient
干预措施: Bland emollient (Other)
结局指标
主要结局
Number of Participants With Excellent Overall Safety Score at End of Treatment.
时间窗: End of treatment
The investigator will assess tolerance at Day 7 and Day 14 using an overall safety score of 0 to 3 defined as; Grade 0-No signs of irritation (excellent); Grade 1-Slight signs of irritation which resolved (Good); Grade 2-Clear signs of irritation (Fair); Grade 3-Patient discontinued due to irritation(Poor).
Subjects With Investigator Global Assessment (IGA) Success (IGA of 0 or 1) at End of Treatment (Day 7 or 14).
时间窗: end of treatment (Day 7 or 14)
IGA scored on scale of 0 (clear) to 4 (severe).
次要结局
- Precent Reduction From Baseline for Scaling at End of Treatment.(From Baseline to end of treatment (Day 7 or 14))
- Percent Reduction From Baseline for Oiliness at End of Treatment.(From Baseline to end of treatment (Day 7 or 14))
- Percent Reduction From Baseline for Crusting at End of Treatment.(From Baseline to end of treatment (Day 7 or 14))
- Percent Reduction From Baseline for Erythema at End of Treatment.(From Baseline to end of treatment (Day 7 or 14))